Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas
NCT ID: NCT01960569
Last Updated: 2013-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2013-10-31
2014-04-30
Brief Summary
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200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters
Detailed Description
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\* 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters
* Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema
* Study duration : 6 months
* Selection of trial subjects:
Inclusion Criteria :
1. Age of patients between 20 and 60 years old.
2. Patients with all types of haematomas.
Exclusion Criteria:
1. Presence of infected wound requiring hospitalization or surgical intervention.
2. History of allergy or hypersensitivity to any of the ingredients.
3. Patients with coagulation disorders like haemophilia.
4. Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
5. Patients who are taking digestive enzymes like alfa chemotrypsin.
* Target parameters :
1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.
2.Size of oedema : by measurement of oedema circumference
3.Pain (by Vas score).
4.Change in colour ( by colour grade scale ) .
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 : active product (Thrombexx)
100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment
active product ( Thrombexx) assigned to arm 1
Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete
Arm 2 : Placebo
100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment
Placebo assigned to arm 2
Interventions
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active product ( Thrombexx) assigned to arm 1
Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete
Placebo assigned to arm 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with all types of haematoma.
Exclusion Criteria
* History of allergy or hypersensitivity to any of the ingredients.
* Patients with coagulation disorders like haemophilia.
* Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
* Patients who are taking digestive enzymes like alfa chemotrypsin.
20 Years
60 Years
ALL
No
Sponsors
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MinaPharm Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Mahmoud Hafez, Professor
Role: PRINCIPAL_INVESTIGATOR
6th October university
Ahmed Moneer, Dr
Role: STUDY_CHAIR
6th october university
Locations
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Prof. Mahmoud Hafez
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Ahmed Moneer, Dr
Role: primary
References
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El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan.
Other Identifiers
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Minpharm07052012
Identifier Type: -
Identifier Source: org_study_id